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FDA 510(k)

POSTERIOR ANNULOPLASTY BAND (MODEL 607)

K-Number: K960356 · 1996-08-27

ApplicantThe Heart Valve Div. Medtronic Cardiovascular Surg
Decision Date1996-08-27
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

POSTERIOR ANNULOPLASTY BAND (MODEL 607) is the device name listed in this FDA 510(k) record. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. It received FDA 510(k) clearance on 1996-08-27 under 510(k) number K960356. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the POSTERIOR ANNULOPLASTY BAND (MODEL 607)?

POSTERIOR ANNULOPLASTY BAND (MODEL 607) is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. The 510(k) number is K960356.

When did POSTERIOR ANNULOPLASTY BAND (MODEL 607) receive FDA 510(k) clearance?

POSTERIOR ANNULOPLASTY BAND (MODEL 607) received FDA 510(k) clearance on 1996-08-27, under 510(k) number K960356.

Who is the listed applicant for POSTERIOR ANNULOPLASTY BAND (MODEL 607)?

The FDA 510(k) record lists The Heart Valve Div. Medtronic Cardiovascular Surg as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POSTERIOR ANNULOPLASTY BAND (MODEL 607)?

The FDA product code for POSTERIOR ANNULOPLASTY BAND (MODEL 607) is KRH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The Heart Valve Div. Medtronic Cardiovascular Surg as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980534DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608HK944956UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491K922269UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493K914602DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

Related Devices (Code: KRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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